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| Molecular Weight | 225.20 g/mol |
|---|---|
| Molecular Formula | C8H11N5O3 |
| XLogP3 | -1.6 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 4 |
| Exact Mass | 225.08618923 g/mol |
| Monoisotopic Mass | 225.08618923 g/mol |
| Topological Polar Surface Area | 115 A^2 |
| Heavy Atom Count | 16 |
| Formal Charge | 0 |
| Complexity | 308 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 8 | |
|---|---|
| Drug Name | Acyclovir |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Capsule; Suspension |
| Route | Topical; Oral |
| Strength | 5%; 200mg/5ml; 200mg; 800mg; 400mg |
| Market Status | Prescription |
| Company | Amneal Pharms; Mylan Pharms; Ranbaxy; Hetero Labs Ltd V; Hi Tech Pharma; Actavis Mid Atlantic; Teva; Cadila Pharms; Apotex; Zydus Pharms Usa; Carlsbad; Mylan; Stason; Dava Pharms |
| 2 of 8 | |
|---|---|
| Drug Name | Acyclovir sodium |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | Acyclovir is a synthetic nucleoside analog active against herpes viruses. Acyclovir for Injection USP is a sterile lyophilized powder for intravenous administration only. Each 500 mg vial contains 500 mg of acyclovir and 49 mg of sodium, and each 100... |
| Active Ingredient | Acyclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 50mg base/ml; eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Bedford; Fresenius Kabi Usa; Aurobindo Pharma |
| 3 of 8 | |
|---|---|
| Drug Name | Sitavig |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see ClinicalPharmacology (12.3)]. Acyclovir is a synthetic purine nucleoside analogue active against herpes viruses. Th... |
| Active Ingredient | Acyclovir |
| Dosage Form | Tablet |
| Route | Buccal |
| Strength | 50mg |
| Market Status | Prescription |
| Company | Innocutis Holdings |
| 4 of 8 | |
|---|---|
| Drug Name | Zovirax |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Cream; Capsule; Suspension |
| Route | Oral; Topical |
| Strength | 200mg/5ml; 200mg; 800mg; 400mg; 5% |
| Market Status | Prescription |
| Company | Delcor Asset; Valeant Bermuda |
| 5 of 8 | |
|---|---|
| Drug Name | Acyclovir |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Capsule; Suspension |
| Route | Topical; Oral |
| Strength | 5%; 200mg/5ml; 200mg; 800mg; 400mg |
| Market Status | Prescription |
| Company | Amneal Pharms; Mylan Pharms; Ranbaxy; Hetero Labs Ltd V; Hi Tech Pharma; Actavis Mid Atlantic; Teva; Cadila Pharms; Apotex; Zydus Pharms Usa; Carlsbad; Mylan; Stason; Dava Pharms |
| 6 of 8 | |
|---|---|
| Drug Name | Acyclovir sodium |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | Acyclovir is a synthetic nucleoside analog active against herpes viruses. Acyclovir for Injection USP is a sterile lyophilized powder for intravenous administration only. Each 500 mg vial contains 500 mg of acyclovir and 49 mg of sodium, and each 100... |
| Active Ingredient | Acyclovir sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 50mg base/ml; eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Bedford; Fresenius Kabi Usa; Aurobindo Pharma |
| 7 of 8 | |
|---|---|
| Drug Name | Sitavig |
| PubMed Health | Acyclovir |
| Drug Classes | Antiviral |
| Drug Label | SITAVIG (acyclovir) buccal tablet is applied topically to the gum and releases acyclovir as the buccal tablet gradually dissolves [see ClinicalPharmacology (12.3)]. Acyclovir is a synthetic purine nucleoside analogue active against herpes viruses. Th... |
| Active Ingredient | Acyclovir |
| Dosage Form | Tablet |
| Route | Buccal |
| Strength | 50mg |
| Market Status | Prescription |
| Company | Innocutis Holdings |
| 8 of 8 | |
|---|---|
| Drug Name | Zovirax |
| Drug Label | ZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Cream 5% is a formulation for topical administration. Each gram of ZOVIRAXCream 5% contains 50mg of acyclovir and the following inactiv... |
| Active Ingredient | Acyclovir |
| Dosage Form | Ointment; Tablet; Cream; Capsule; Suspension |
| Route | Oral; Topical |
| Strength | 200mg/5ml; 200mg; 800mg; 400mg; 5% |
| Market Status | Prescription |
| Company | Delcor Asset; Valeant Bermuda |
API SUPPLIERS
Apex Healthcare: ISO 9001:2008, WHO-GMP, US FDA-approved manufacturer & exporter of APIs, bulk drugs, and formulations.
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm :
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Certificate Number : CEP 1997-084 - Rev 12
Status : Valid
Issue Date : 2024-05-30
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 1997-125 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2011-03-15
Type : Chemical
Substance Number : 968
Certificate Number : R0-CEP 2008-169 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-03-15
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 2003-041 - Rev 05
Status : Valid
Issue Date : 2020-10-20
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 1998-126 - Rev 03
Status : Valid
Issue Date : 2017-04-27
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 2007-213 - Rev 01
Status : Valid
Issue Date : 2018-03-21
Type : Chemical
Substance Number : 968
Certificate Number : R0-CEP 2002-004 - Rev 01
Status : Expired
Issue Date : 2004-11-30
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 1997-031 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2005-02-10
Type : Chemical
Substance Number : 968
Certificate Number : R1-CEP 1998-148 - Rev 05
Status : Valid
Issue Date : 2016-12-08
Type : Chemical
Substance Number : 968
Certificate Number : R0-CEP 2000-086 - Rev 01
Status : Expired
Issue Date : 2004-12-13
Type : Chemical
Substance Number : 968
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Apex Healthcare: ISO 9001:2008, WHO-GMP, US FDA-approved manufacturer & exporter of APIs, bulk drugs, and formulations.
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm : 4710, 4711, 470748, 470749, GIDC,Industrial Estate, Ankleshwar, Dist.Bharuch-393...
Apex Healthcare: ISO 9001:2008, WHO-GMP, US FDA-approved manufacturer & exporter of APIs, bulk drugs, and formulations.
Date of Issue : 2024-03-01
Valid Till : 2026-12-31
Written Confirmation Number : WC-0409
Address of the Firm : 4710, 4711, 4707-A/8, 4707-A/9, GIDC, Industrial Estate, Ankleshwar, Dist.Bharuc...
Date of Issue : 2020-09-30
Valid Till : 2022-07-02
Written Confirmation Number : WC-0119A9
Address of the Firm : Plot No. 35, 36, 38, 39, 40, 49, 50, & 51, Phase IV, IDA, Jeedimetla, Medchal-Ma...
Date of Issue : 2022-06-28
Valid Till : 2025-07-02
Written Confirmation Number : WC-247
Address of the Firm : Plot No D-5/8, D-5/9, MIDC Turbhe,\r\nMumbai-400703, Maharashtra, India\r\n
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm : Plot No. 1, Hetero SEZ Infrastructure Ltd., Narasapuram, Visakhapatnam-531 081, ...
Date of Issue : 2021-01-22
Valid Till : 2023-08-01
Written Confirmation Number : WC-0275
Address of the Firm : N-211/2/10, MIDC, Boisar, Dist-Thane-401506, Mahrashtra
Date of Issue : 2022-10-27
Valid Till : 2025-07-22
Written Confirmation Number : WC-0167
Address of the Firm : Unit No.1, Plot No.187, IInd Phase, GIDC Vapi-396195, Dist-Valsad, India
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandai, Sangareddy District, T...
Date of Issue : 2020-04-16
Valid Till : 2022-07-06
Written Confirmation Number : WC-0378A2
Address of the Firm : Plot No 100 Sector 56, HSIIDC, Kundli district sonepat, Haryana
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0042
Address of the Firm : Plot No.262, 263, IDA, Pashamylaram, Medak District, A.P
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Acyclovir Zentiva
Dosage Form : Cream
Dosage Strength : 50mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Acyclovir Zentiva
Dosage Form : Cream
Dosage Strength : 50mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Cyclivex
Dosage Form : TAB
Dosage Strength : 200mg
Packaging : 25X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Cyclivex
Dosage Form : TAB
Dosage Strength : 400mg
Packaging : 70X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Aspen Acyclovir 250 Mg
Dosage Form : POI
Dosage Strength : 250mg/10ml
Packaging : 10X5mg/10ml
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Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
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Dosage Strength : 250MG
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Registration Country : France
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
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Registration Country : Latvia
Brand Name : Herpelān
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Latvia
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Aciclovir
Dosage Form : Cream
Dosage Strength : 5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Aciclovir
Dosage Form : DC Granules
Dosage Strength : 200MG
Packaging :
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Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Aciclovir
Dosage Form : DC Granules
Dosage Strength : 400MG
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Registration Country : India
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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Registration Country : Switzerland
Brand Name : Acyclovir Zentiva
Dosage Form : Cream
Dosage Strength : 50mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Acyclovir Zentiva
Dosage Form : Cream
Dosage Strength : 50mg/g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 200 mg
Packaging : 25 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 400 mg
Packaging : 25 UNITS 400 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS
Dosage Form : Tablets
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR THINKS PHARMA
Dosage Form : Tablets
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLIN
Dosage Form : Tablets
Dosage Strength : 400 mg
Packaging : 25 UNITS 400 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLIN
Dosage Form : Tablets
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : ACICLOVIR DOROM
Dosage Form : Tablets
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Anti
Dosage Form : CREAM
Dosage Strength : 5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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DOSAGE - CAPSULE;ORAL - 200MG **Federal Regis...DOSAGE - CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18828
DOSAGE - SUSPENSION;ORAL - 200MG/5ML
USFDA APPLICATION NUMBER - 19909
DOSAGE - TABLET;ORAL - 400MG **Federal Regist...DOSAGE - TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20089
DOSAGE - TABLET;ORAL - 800MG **Federal Regist...DOSAGE - TABLET;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20089
DOSAGE - CREAM;TOPICAL - 5%;1%
USFDA APPLICATION NUMBER - 22436
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ABOUT THIS PAGE
59
PharmaCompass offers a list of Aciclovir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Aciclovir manufacturer or Aciclovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aciclovir manufacturer or Aciclovir supplier.
PharmaCompass also assists you with knowing the Aciclovir API Price utilized in the formulation of products. Aciclovir API Price is not always fixed or binding as the Aciclovir Price is obtained through a variety of data sources. The Aciclovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aciclovirum [Latin] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aciclovirum [Latin], including repackagers and relabelers. The FDA regulates Aciclovirum [Latin] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aciclovirum [Latin] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Aciclovirum [Latin] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aciclovirum [Latin] supplier is an individual or a company that provides Aciclovirum [Latin] active pharmaceutical ingredient (API) or Aciclovirum [Latin] finished formulations upon request. The Aciclovirum [Latin] suppliers may include Aciclovirum [Latin] API manufacturers, exporters, distributors and traders.
click here to find a list of Aciclovirum [Latin] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aciclovirum [Latin] DMF (Drug Master File) is a document detailing the whole manufacturing process of Aciclovirum [Latin] active pharmaceutical ingredient (API) in detail. Different forms of Aciclovirum [Latin] DMFs exist exist since differing nations have different regulations, such as Aciclovirum [Latin] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aciclovirum [Latin] DMF submitted to regulatory agencies in the US is known as a USDMF. Aciclovirum [Latin] USDMF includes data on Aciclovirum [Latin]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aciclovirum [Latin] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Aciclovirum [Latin] Drug Master File in Japan (Aciclovirum [Latin] JDMF) empowers Aciclovirum [Latin] API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Aciclovirum [Latin] JDMF during the approval evaluation for pharmaceutical products. At the time of Aciclovirum [Latin] JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Aciclovirum [Latin] Drug Master File in Korea (Aciclovirum [Latin] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aciclovirum [Latin]. The MFDS reviews the Aciclovirum [Latin] KDMF as part of the drug registration process and uses the information provided in the Aciclovirum [Latin] KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aciclovirum [Latin] KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Aciclovirum [Latin] API can apply through the Korea Drug Master File (KDMF).
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A Aciclovirum [Latin] CEP of the European Pharmacopoeia monograph is often referred to as a Aciclovirum [Latin] Certificate of Suitability (COS). The purpose of a Aciclovirum [Latin] CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aciclovirum [Latin] EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aciclovirum [Latin] to their clients by showing that a Aciclovirum [Latin] CEP has been issued for it. The manufacturer submits a Aciclovirum [Latin] CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aciclovirum [Latin] CEP holder for the record. Additionally, the data presented in the Aciclovirum [Latin] CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aciclovirum [Latin] DMF.
A Aciclovirum [Latin] CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aciclovirum [Latin] CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Aciclovirum [Latin] written confirmation (Aciclovirum [Latin] WC) is an official document issued by a regulatory agency to a Aciclovirum [Latin] manufacturer, verifying that the manufacturing facility of a Aciclovirum [Latin] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aciclovirum [Latin] APIs or Aciclovirum [Latin] finished pharmaceutical products to another nation, regulatory agencies frequently require a Aciclovirum [Latin] WC (written confirmation) as part of the regulatory process.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Aciclovirum [Latin] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aciclovirum [Latin] API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Aciclovirum [Latin] as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Aciclovirum [Latin] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aciclovirum [Latin] NDC to their finished compounded human drug products, they may choose to do so.
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Aciclovirum [Latin] Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Aciclovirum [Latin] GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Aciclovirum [Latin] GMP manufacturer or Aciclovirum [Latin] GMP API supplier for your needs.
A Aciclovirum [Latin] CoA (Certificate of Analysis) is a formal document that attests to Aciclovirum [Latin]'s compliance with Aciclovirum [Latin] specifications and serves as a tool for batch-level quality control.
Aciclovirum [Latin] CoA mostly includes findings from lab analyses of a specific batch. For each Aciclovirum [Latin] CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Aciclovirum [Latin] may be tested according to a variety of international standards, such as European Pharmacopoeia (Aciclovirum [Latin] EP), Aciclovirum [Latin] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aciclovirum [Latin] USP).
